NCT05105178已完成不适用
Effect of a Repeated Verbal Stimulation of Orientation on Emergence Agitation After General Anesthesia: a Randomized Double-blind Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Incidence of emergence agitation at operating room (OR)
研究概览
简要总结
The purpose of this study is to investigate whether information of the orientation such as time, place, and patient's own name can reduce emergence delirium after general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective laparoscopic or robot-assisted abdominal surgery
排除标准
- •Patients' refusal
- •Change in operation schedule
- •American Society of Anaesthesiologists (ASA) physical status Ⅳ
- •Day surgery
- •Neurocognitive impairment, hearing disorder
- •Psychological drug intake
- •Experience of general anesthesia or sedation within 1 month
- •Drop out Criteria
- •Changes in operation schedule (e.g. unexpected collaborative surgery, conversion to laparotomy, delay of the schedule to night-duty hours)
- •Significant protocol violation
结局指标
主要结局
Incidence of emergence agitation at operating room (OR)
时间窗: 20 minutes after anesthesia emergence
Riker sedation agitated scale ≥5
次要结局
- Analgesics requirement(Postoperative 24 hours)
- Time to emergence(20 minutes after anesthesia emergence)
- Incidence of emergence agitation at PACU(30 minutes after PACU adminstration)
- Incidence of postoperative delirium(30 minutes after PACU adminstration / Postoperative 24 hours)
- maximal Riker sedation agitated scale during emergence(20 minutes after anesthesia emergence)
- Bispectral index (BIS)(20 minutes after anesthesia emergence)
- Postoperative Pain(10/20/30 minutes after PACU administation / Postoperative 24 hours)
- Incidence of dangerous emergence agitation(20 minutes after anesthesia emergence)
- PACU stay(up to 3 hours after PACU administration)
- Postoperative opioid consumption(30 minutes after PACU adminstration / Postoperative 24 hours)
- Postoperative quality of recovery(Postoperative 24 hours)
研究者
Bo Rim Kim
Clinical assistant professor
Seoul National University Hospital
研究点 (1)
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